University of Pennsylvania - Philadelphia, PA

posted 22 days ago

Full-time - Mid Level
Philadelphia, PA
Educational Services

About the position

The Clinical Research Program Manager B at the Abramson Cancer Center is responsible for overseeing the clinical research portfolio of the Cell Therapy & Transplant Research Team. This role involves managing the start-to-end processes of clinical trials, ensuring compliance with regulatory standards, and collaborating with various stakeholders to enhance research operations. The Program Manager will supervise research staff, manage ongoing projects, and ensure the successful execution of clinical trials aimed at advancing cancer care.

Responsibilities

  • Oversee all aspects of the clinical research portfolio for the Cell Therapy & Transplant Research Team.
  • Assist with study feasibility and selection, prioritization of the team's work, and manage trial initiation and ongoing study management.
  • Actively manage ongoing research projects and troubleshoot operational issues.
  • Supervise clinical research nurses, coordinators, and research assistants, including recruitment, training, and performance management.
  • Collaborate with internal and external stakeholders to develop project plans and support clinical research proposals.
  • Monitor and report on the status of all studies, including accrual, data entry, and patient issues.
  • Ensure compliance with regulatory requirements and maintain documentation for studies.
  • Participate in the development and maintenance of study-specific case report forms and source document tools.

Requirements

  • Bachelor's degree required with 5-7 years of related experience, or a Master's degree with 3-5 years of related experience.
  • Effective problem-solving abilities and strong organizational skills.
  • Knowledge of IRB and human research protection regulations.
  • Oncology clinical research experience preferred.

Nice-to-haves

  • Experience with electronic Clinical Trials Management Systems (CTMS).
  • Familiarity with GCP, FDA regulations, and clinical trial budgeting.

Benefits

  • Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance.
  • Tuition assistance for employees and their families.
  • Generous retirement plans with various investment options.
  • Substantial time away from work for personal needs.
  • Long-term care insurance options.
  • Wellness and work-life resources.
  • Professional and personal development resources.
  • Access to university resources and cultural activities.
  • Discounts and special services for faculty and staff.
  • Flexible work hours and options.
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